Radiation Oncology Department, Clinico San Carlos Hospital, Madrid, Spain; Investigation Institute, Clinico San Carlos Hospital, Madrid, Spain.
Investigation Institute, Clinico San Carlos Hospital, Madrid, Spain; Radiation Oncology Department, Clinico San Carlos Hospital, Madrid, Spain; Faculty of Medicine. Complutense University of Madrid, Spain.
Radiother Oncol. 2022 Jun;171:25-29. doi: 10.1016/j.radonc.2022.03.015. Epub 2022 Mar 31.
To evaluate the results of low-dose radiation therapy (LD-RT) to lungs in the management of patients with COVID-19 pneumonia.
We conducted a prospective phase I-II trial enrolling COVID-19 patients ≥50 years-old, with bilateral lung involvement at imaging study and oxygen requirement (oxygen saturation ≤93% on room air). Patients received 1 Gy to whole lungs in a single fraction. Primary outcome was a radiological response assessed as severity and extension scores at days +3 and +7. Secondary outcomes were toxicity (CTCAE v5.0), days of hospitalization, changes in inflammatory blood parameters (ferritin, lymphocytes, C-reactive protein, d-dimer and LDH) and SatO/FiO index (SAFI), at day +3 and +7. Descriptive analyses were summarized as means with standard deviation (SD) and/or medians with interquartile ranges (IQR). A Wilcoxon sign rank test for paired data was used to assess the CT scores and Chi Square was used to assess for comparison of categorical variables.
Forty-one patients were included. Median age was 71 (IQR 60-84). Eighteen patients (44%) previously received an anti-COVID treatment (tocilizumab, lopinavir/ritonavir, remdesivir) and thirty-two patients (84%) received steroids during LD-RT. The extension score improved significantly (p = 0.02) on day +7. Mean baseline extension score was 13.7 (SD ± 4.9) with a score of 12.2 (±5.2) at day 3, and 12.4 ± 4.7 at day 7. No differences were found in the severity score. SAFI improved significantly on day +3 and +7 (p < 0.01). Median SAFI on day 0 was 147 (IQR 118-264), 230 (IQR 120-343) on day +3 and 293 (IQR 121-353) on day +7. Significant decrease was found in C-reactive protein on day +7 (p = 0.02) and in lymphocytes counts on day +3 and +7 (p = 0.02). The median number of days in hospital after RT was 11 (range 4-78). With a median follow-up of 60 days after LD-RT, 26 (63%) patients were discharged, 11 (27%) died because of COVID respiratory failure and 4 (10%) died of other causes.
LD-RT is a feasible and well-tolerated treatment that could lead to rapid clinical improvement. Large randomized trials would be required to establish the efficacy of LD-RT to treat COVID-19 pneumonia.
评估低剂量放射疗法（LD-RT）在 COVID-19 肺炎患者管理中的疗效。
我们进行了一项前瞻性 I 期- II 期试验，纳入≥50 岁的 COVID-19 患者，影像学检查显示双肺受累且需要吸氧（室内空气时血氧饱和度≤93%）。患者接受单次 1Gy 全肺照射。主要结局为第 3 天和第 7 天的严重程度和扩展评分的放射学反应。次要结局为毒性（CTCAE v5.0）、住院天数、炎症血液参数（铁蛋白、淋巴细胞、C 反应蛋白、D-二聚体和 LDH）和 SatO/FiO 指数（SAFI）的变化，在第 3 天和第 7 天。描述性分析总结为平均值±标准差（SD）和/或中位数±四分位距（IQR）。采用 Wilcoxon 符号秩检验对配对数据进行评估，采用卡方检验比较分类变量。
共纳入 41 例患者。中位年龄为 71（IQR 60-84）岁。18 例（44%）患者曾接受抗 COVID 治疗（托珠单抗、洛匹那韦/利托那韦、瑞德西韦），32 例（84%）患者在 LD-RT 期间接受类固醇治疗。第 7 天的扩展评分显著改善（p=0.02）。基线时的平均扩展评分是 13.7（SD±4.9），第 3 天为 12.2（±5.2），第 7 天为 12.4±4.7。严重程度评分无差异。第 3 天和第 7 天 SAFI 显著改善（p<0.01）。第 0 天 SAFI 的中位数为 147（IQR 118-264），第 3 天为 230（IQR 120-343），第 7 天为 293（IQR 121-353）。第 7 天 C 反应蛋白显著下降（p=0.02），第 3 天和第 7 天淋巴细胞计数也显著下降（p=0.02）。RT 后住院中位数为 11 天（范围 4-78）。在 LD-RT 后中位随访 60 天，26 例（63%）患者出院，11 例（27%）因 COVID 呼吸衰竭死亡，4 例（10%）因其他原因死亡。
LD-RT 是一种可行且耐受良好的治疗方法，可迅速改善临床症状。需要进行大型随机试验来确定 LD-RT 治疗 COVID-19 肺炎的疗效。
